Handling of Deviations in Pharmaceutical Companies

Abstract

Deviations are the differences that are measured between the expected or normal values and the observed values for a product or process condition from a procedure or a documented standard. Deviations occur almost every day in the pharmaceutical industry and handling deviations and minimizing their recurrence of them has very critical considerations in the quality management system of the pharmaceutical industry. During my carrier journey in Cipla, Glenmark, Alembic, Lupin, Mylan I faced several types of deviation. A few case studies are incorporated in this article. This article explains the procedure for handling deviations by identifying the deviation, understanding its criticality, conducting root cause analysis and suggesting corrective and preventive action for it. This is explained through various case studies such as out-of-calibration equipment, facility modification, temperature excursions, of specification during the manufacturing process, with a detailed process about the handling of deviations.